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Сочетанная терапия ингибиторами протонной помпы и клопидогрелом: фокус на сердечно-сосудистый риск
Сочетанная терапия ингибиторами протонной помпы и клопидогрелом: фокус на сердечно-сосудистый риск
Кочетков А.И., Остроумова О.Д., Кравченко Е.В. и др. Сочетанная терапия ингибиторами протонной помпы и клопидогрелом: фокус на сердечно-сосудистый риск. Consilium Medicum. 2019; 21 (1): 56–66. DOI: 10.26442/20751753.2019.1.190194
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Аннотация
Цель. Провести анализ доступных исследований по проблеме потенциального взаимодействия ингибиторов протонной помпы (ИПП) и клопидогрела и оценить влияние сочетанной терапии этими препаратами на частоту сердечно-сосудистых осложнений.
Материалы и методы. Проанализированные данные 43 зарубежных и отечественных литературных источников, в числе которых международные клинические рекомендации, рандомизированные и проспективные клинические исследования, когортные, ретроспективные и регистровые работы, метаанализы и систематические обзоры.
Результаты. Рассмотрена проблема взаимодействия ИПП и ингибитора P2Y12-рецепторов тромбоцитов клопидогрела с точки зрения сердечно-сосудистого риска и влияния на частоту основных неблагоприятных сердечно-сосудистых событий (острый коронарный синдром, тромбоз стента, необходимость реваскуляризации миокарда, инсульт, инфаркт миокарда, общая и/или сердечно-сосудистая смертность, явные и/или скрытые желудочно-кишечные кровотечения) у пациентов, находящихся на двойной антитромбоцитарной терапии. Представлены позиции актуальных международных рекомендаций относительно возможности и необходимости сочетанного применения указанных групп препаратов. Обсуждены данные обширного массива исследований по влиянию ИПП на клиническую эффективность клопидогрела. Результаты проанализированных работ свидетельствуют о повышенном риске развития неблагоприятных сердечно-сосудистых событий в группе пациентов с ишемической болезнью сердца, принимающих сопутствующую терапию ИПП. В частности, в ряде метаанализов продемонстрировано, что одновременное применение ацетилсалициловой кислоты, клопидогрела и ИПП уменьшает частоту желудочно-кишечных кровотечений, но вместе с этим имеет место повышенный риск развития основных неблагоприятных сердечно-сосудистых событий, возрастают вероятность тромбоза стентов и необходимость выполнения процедур реваскуляризации. Эти данные, однако, не нашли подтверждения в малочисленных рандомизированных клинических исследованиях.
Заключение. Учитывая имеющиеся литературные данные, можно сделать вывод о необходимости проведения крупных хорошо спланированных рандомизированных клинических исследований для окончательного ответа на вопрос о безопасности применения ИПП у больных, перенесших чрескожное коронарное вмешательство или аортокоронарное шунтирование, в том числе по поводу острого коронарного синдрома.
Ключевые слова: клопидогрел, ингибиторы протонной помпы, основные неблагоприятные сердечно-сосудистые события, сердечно-сосудистый риск, доказательная медицина.
Материалы и методы. Проанализированные данные 43 зарубежных и отечественных литературных источников, в числе которых международные клинические рекомендации, рандомизированные и проспективные клинические исследования, когортные, ретроспективные и регистровые работы, метаанализы и систематические обзоры.
Результаты. Рассмотрена проблема взаимодействия ИПП и ингибитора P2Y12-рецепторов тромбоцитов клопидогрела с точки зрения сердечно-сосудистого риска и влияния на частоту основных неблагоприятных сердечно-сосудистых событий (острый коронарный синдром, тромбоз стента, необходимость реваскуляризации миокарда, инсульт, инфаркт миокарда, общая и/или сердечно-сосудистая смертность, явные и/или скрытые желудочно-кишечные кровотечения) у пациентов, находящихся на двойной антитромбоцитарной терапии. Представлены позиции актуальных международных рекомендаций относительно возможности и необходимости сочетанного применения указанных групп препаратов. Обсуждены данные обширного массива исследований по влиянию ИПП на клиническую эффективность клопидогрела. Результаты проанализированных работ свидетельствуют о повышенном риске развития неблагоприятных сердечно-сосудистых событий в группе пациентов с ишемической болезнью сердца, принимающих сопутствующую терапию ИПП. В частности, в ряде метаанализов продемонстрировано, что одновременное применение ацетилсалициловой кислоты, клопидогрела и ИПП уменьшает частоту желудочно-кишечных кровотечений, но вместе с этим имеет место повышенный риск развития основных неблагоприятных сердечно-сосудистых событий, возрастают вероятность тромбоза стентов и необходимость выполнения процедур реваскуляризации. Эти данные, однако, не нашли подтверждения в малочисленных рандомизированных клинических исследованиях.
Заключение. Учитывая имеющиеся литературные данные, можно сделать вывод о необходимости проведения крупных хорошо спланированных рандомизированных клинических исследований для окончательного ответа на вопрос о безопасности применения ИПП у больных, перенесших чрескожное коронарное вмешательство или аортокоронарное шунтирование, в том числе по поводу острого коронарного синдрома.
Ключевые слова: клопидогрел, ингибиторы протонной помпы, основные неблагоприятные сердечно-сосудистые события, сердечно-сосудистый риск, доказательная медицина.
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Aim. To analyze accessible studies on the problem of potential interaction of proton pump inhibitors and clopidogrel and to evaluate the influence of combined therapy with these pharmacologic agents on cardiovascular adverse effects development.
Materials and methods. Data from 43 foreign and Russian literature sources including international clinical guidelines, randomized and prospective clinical studies, cohort and retrospective studies, clinical registries, metaanalyses and systematic reviews were analyzed.
Results. The issue of proton pump inhibitors and P2Y12 thrombocytes receptors inhibitor clopidogrel interaction is discussed in the context of cardiovascular risk and influence on essential adverse cardiovascular events (including acute coronary syndrome, stent thrombosis, necessity of myocardial revascularization, stroke, myocardial infarction, all-cause and/or cardiovascular mortality, symptomatic or non- symptomatic gastrointestinal hemorrhage) in patients taking dual antiplatelet therapy. Standpoints of current international guidelines concerning possibility and necessity of theses medicines use in combination are presented. Data from a significant amount of studies on proton pump inhibitors influence on clopidogrel clinical effectiveness are discussed. The results of analyzed studies demonstrate increased risk of adverse cardiovascular events in the group of patients with ischemic heart disease who receive concomitant treatment with proton pump inhibitors. In particular, in several metaanalyses it was demonstrated that concurrent administration of acetosalicylic acid, clopidogrel, and proton pump inhibitors reduces frequency of gastrointestinal hemorrhage, but at the same time increases risk of major adverse cardiovascular events, increases probability of stent thrombosis and necessity of revascularization. Nevertheless, these results were not confirmed in multiple randomized clinical studies.
Conclusion. Considering available literature data we can make a conclusion of necessity of large well-orchestrated randomized clinical studies conduction in order to find a conclusive answer on safety of proton pump inhibitors use in patients after percutaneous coronary intervention or coronary artery bypass surgery, including patients after acute coronary syndrome.
Key words: clopidogrel, proton memory inhibitors, major adverse cardiovascular events, cardiovascular risk, evidence-based medicine.
Materials and methods. Data from 43 foreign and Russian literature sources including international clinical guidelines, randomized and prospective clinical studies, cohort and retrospective studies, clinical registries, metaanalyses and systematic reviews were analyzed.
Results. The issue of proton pump inhibitors and P2Y12 thrombocytes receptors inhibitor clopidogrel interaction is discussed in the context of cardiovascular risk and influence on essential adverse cardiovascular events (including acute coronary syndrome, stent thrombosis, necessity of myocardial revascularization, stroke, myocardial infarction, all-cause and/or cardiovascular mortality, symptomatic or non- symptomatic gastrointestinal hemorrhage) in patients taking dual antiplatelet therapy. Standpoints of current international guidelines concerning possibility and necessity of theses medicines use in combination are presented. Data from a significant amount of studies on proton pump inhibitors influence on clopidogrel clinical effectiveness are discussed. The results of analyzed studies demonstrate increased risk of adverse cardiovascular events in the group of patients with ischemic heart disease who receive concomitant treatment with proton pump inhibitors. In particular, in several metaanalyses it was demonstrated that concurrent administration of acetosalicylic acid, clopidogrel, and proton pump inhibitors reduces frequency of gastrointestinal hemorrhage, but at the same time increases risk of major adverse cardiovascular events, increases probability of stent thrombosis and necessity of revascularization. Nevertheless, these results were not confirmed in multiple randomized clinical studies.
Conclusion. Considering available literature data we can make a conclusion of necessity of large well-orchestrated randomized clinical studies conduction in order to find a conclusive answer on safety of proton pump inhibitors use in patients after percutaneous coronary intervention or coronary artery bypass surgery, including patients after acute coronary syndrome.
Key words: clopidogrel, proton memory inhibitors, major adverse cardiovascular events, cardiovascular risk, evidence-based medicine.
Полный текст
Список литературы
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2. Ibanez B, James S, Agewall S et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2018; 39 (2): 119–77. DOI: 10.1093/eurheartj/ehx393
3. Roffi M, Patrono C, Collet JP et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37 (3): 267–315. DOI: 10.1093/eurheartj/ehv320
4. Valgimigli M, Bueno H, Byrne RA et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39 (3): 213–60. doi: 10.1093/eurheartj/ehx419
5. Gutermann IK, Niggemeier V, Zimmerli LU et al. Gastrointestinal bleeding and anticoagulant or antiplatelet drugs: systematic search for clinical practice guidelines. Medicine (Baltimore). 2015; 94 (1): e377. DOI: 10.1097/MD.0000000000000377
6. Neumann FJ, Sousa-Uva M, Ahlsson A et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019; 40 (2): 87–165. DOI: 10.1093/eurheartj/ehy394
7. Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg 2016; 50 (5): e1-e88.
8. Heidbuchel H, Verhamme P, Alings M et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15 (5): 625–51. DOI: 10.1093/europace/eut083
9. Levine GN, Bates ER, Bittl JA et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2016; 68 (10): 1082–115. DOI: 10.1016/j.jacc.2016.03.513
10. Hu W, Tong J, Kuang X et al. Influence of proton pump inhibitors on clinical outcomes in coronary heart disease patients receiving aspirin and clopidogrel: A meta-analysis. Medicine (Baltimore) 2018; 97 (3): e9638. DOI: 10.1097/MD.0000000000009638
11. Serbin MA, Guzauskas GF, Veenstra DL. Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis. J Manag Care Spec Pharm 2016; 22 (8): 939–47. DOI: 10.18553/jmcp.2016.22.8.939
12. Zairis MN, Tsiaousis GZ, Patsourakos NG et al. The impact of treatment with omeprazole on the effectiveness of clopidogrel drug therapy during the first year after successful coronary stenting. Can J Cardiol 2010; 26 (2): e54-7.
13. Evanchan J, Donnally MR, Binkley P, Mazzaferri E. Recurrence of acute myocardial infarction in patients discharged on clopidogrel and a proton pump inhibitor after stent placement for acute myocardial infarction. Clin Cardiol 2010; 33 (3): 168–71. DOI: 10.1002/clc.20721
14. Harjai KJ, Shenoy C, Orshaw P et al. Clinical outcomes in patients with the concomitant use of clopidogrel and proton pump inhibitors after percutaneous coronary intervention: an analysis from the Guthrie Health Off-Label Stent (GHOST) investigators. Circ Cardiovasc Interv 2011; 4 (2): 162–70. DOI: 10.1161/CIRCINTERVENTIONS.110.958884
15. Aihara H, Sato A, Takeyasu N et al. Effect of individual proton pump inhibitors on cardiovascular events in patients treated with clopidogrel following coronary stenting: results from the Ibaraki Cardiac Assessment Study Registry. Catheter Cardiovasc Interv 2012; 80 (4): 556–63. DOI: 10.1002/ccd.23327
16. Bundhun PK, Teeluck AR, Bhurtu A, Huang WQ. Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty: a systematic review and meta-analysis of recently published studies (2012–2016). BMC Cardiovasc Disord 2017; 17 (1): 3. DOI: 10.1186/s12872-016-0453-6
17. Douglas IJ, Evans SJ, Hingorani AD et al. Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs. BMJ 2012; 345: e4388. DOI: 10.1136/bmj.e4388
18. Bhurke SM, Martin BC, Li C et al. Effect of the clopidogrel-proton pump inhibitor drug interaction on adverse cardiovascular events in patients with acute coronary syndrome. Pharmacotherapy 2012; 32 (9): 809–18. DOI: 10.1002/j.1875-9114.2012.01112.x
19. Dunn SP, Steinhubl SR, Bauer D et al. Impact of proton pump inhibitor therapy on the efficacy of clopidogrel in the CAPRIE and CREDO trials. J Am Heart Assoc 2013; 2 (1): e004564. DOI: 10.1161/JAHA.112.004564
20. Goodman SG, Clare R, Pieper KS et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation 2012; 125 (8): 978–86. DOI: 10.1161/CIRCULATIONAHA.111.032912
21. Hsieh CF, Huang WF, Chiang YT et al. Effects of Clopidogrel and Proton Pump Inhibitors on Cardiovascular Events in Patients with Type 2 Diabetes Mellitus after Drug-Eluting Stent Implantation: A Nationwide Cohort Study. PLoS One 2015; 10 (8): e0135915. DOI: 10.1371/journal.pone.0135915
22. Chitose T, Hokimoto S, Oshima S et al. Clinical outcomes following coronary stenting in Japanese patients treated with and without proton pump inhibitor. Circ J 2012; 76 (1): 71–8.
23. Macaione F, Montaina C, Evola S et al. Impact of dual antiplatelet therapy with proton pump inhibitors on the outcome of patients with acute coronary syndrome undergoing drug-eluting stent implantation. ISRN Cardiol 2012; 2012: 692761. DOI: 10.5402/2012/692761
24. Burkard T, Kaiser CA, Brunner-La Rocca H et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med 2012; 271 (3): 257–63. DOI: 10.1111/j.1365-2796.2011.02423.x.
25. Gargiulo G, Costa F, Ariotti S et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: Insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study trial. Am Heart J 2016; 174: 95–102. DOI: 10.1016/j.ahj.2016.01.015
26. Steinhubl SR, Berger PB, Mann JT 3rd et al; CREDO Investigators. Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288 (19): 2411–20.
27. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet 1996; 348 (9038): 1329–39.
28. Huang B, Huang Y, Li Y et al. Adverse cardiovascular effects of concomitant use of proton pump inhibitors and clopidogrel in patients with coronary artery disease: a systematic review and meta-analysis. Arch Med Res 2012; 43 (3): 212–24. DOI: 10.1016/j.arcmed.2012.04.004
29. Focks JJ, Brouwer MA, van Oijen MG et al. Concomitant use of clopidogrel and proton pump inhibitors: impact on platelet function and clinical outcome- a systematic review. Heart 2013; 99 (8): 520–7. DOI: 10.1136/heartjnl-2012-302371
30. Demcsák A, Lantos T, Bálint ER et al. PPIs Are Not Responsible for Elevating Cardiovascular Risk in Patients on Clopidogrel-A Systematic Review and Meta-Analysis. Front Physiol 2018; 9: 1550. DOI: 10.3389/fphys.2018.01550
31. Melloni C, Washam JB, Jones WS et al. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review. Circ Cardiovasc Qual Outcomes 2015; 8 (1): 47–55. DOI: 10.1161/CIRCOUTCOMES.114.001177
32. Ng FH, Tunggal P, Chu WM et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol 2012; 107 (3): 389–96. DOI: 10.1038/ajg.2011.385
33. Yano H, Tsukahara K, Morita S et al. Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: a prospective, randomized, multicenter study. Circ J 2012; 76 (11): 2673–80.
34. Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology 2011; 140 (3): 791–8. DOI: 10.1053/j.gastro.2010.11.056
35. Ren YH, Zhao M, Chen YD et al. Omeprazole affects clopidogrel efficacy but not ischemic events in patients with acute coronary syndrome undergoing elective percutaneous coronary intervention. Chin Med J (Engl) 2011; 124 (6): 856–61.
36. Bhatt DL, Cryer BL, Contant CF et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010; 363 (20): 1909–17. DOI: 10.1056/NEJMoa1007964
37. Cai J, Wu Q, Fan L et al. Impact of different proton pump inhibitors on the antiplatelet activity of clopidogrel in combination with aspirin for patients undergoing coronary stent implantation. Zhongguo Ying Yong Sheng Li Xue Za Zhi 2010; 26 (3): 266–9.
38. Weisz G, Smilowitz NR, Kirtane AJ et al. Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study. Circ Cardiovasc Interv 2015; 8 (10). pii: e001952. DOI: 10.1161/CIRCINTERVENTIONS.114.001952
39. O'Donoghue ML, Braunwald E, Antman EM et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet 2009; 374 (9694): 989–97. DOI: 10.1016/S0140-6736(09)61525-7
40. Tentzeris I, Jarai R, Farhan S et al. Impact of concomitant treatment with proton pump inhibitors and clopidogrel on clinical outcome in patients after coronary stent implantation. Thromb Haemost 2010; 104 (6): 1211–8. DOI: 10.1160/TH10-04-0218
41. Sarafoff N, Sibbing D, Sonntag U et al. Risk of drug-eluting stent thrombosis in patients receiving proton pump inhibitors. Thromb Haemost 2010; 104 (3): 626–32. DOI: 10.1160/TH09-11-0800
42. Chandrasekhar J, Bansilal S, Baber U et al. Impact of proton pump inhibitors and dual antiplatelet therapy cessation on outcomes following percutaneous coronary intervention: Results From the PARIS Registry. Catheter Cardiovasc Interv 2017; 89 (7): E217-E225. DOI: 10.1002/ccd.26716
43. Komarov A.L., Shakhmatova O.O., Muraseeva V. et al. Priem ingibitorov protonnoi pompy i prognoz patsientov posle planovykh chreskozhnykh koronarnykh vmeshatel'stv. Terapevticheskii arkhiv. 2018; 9: 92–100 (in Russian).
2. Ibanez B, James S, Agewall S et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2018; 39 (2): 119–77. DOI: 10.1093/eurheartj/ehx393
3. Roffi M, Patrono C, Collet JP et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37 (3): 267–315. DOI: 10.1093/eurheartj/ehv320
4. Valgimigli M, Bueno H, Byrne RA et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39 (3): 213–60. doi: 10.1093/eurheartj/ehx419
5. Gutermann IK, Niggemeier V, Zimmerli LU et al. Gastrointestinal bleeding and anticoagulant or antiplatelet drugs: systematic search for clinical practice guidelines. Medicine (Baltimore). 2015; 94 (1): e377. DOI: 10.1097/MD.0000000000000377
6. Neumann FJ, Sousa-Uva M, Ahlsson A et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019; 40 (2): 87–165. DOI: 10.1093/eurheartj/ehy394
7. Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg 2016; 50 (5): e1-e88.
8. Heidbuchel H, Verhamme P, Alings M et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15 (5): 625–51. DOI: 10.1093/europace/eut083
9. Levine GN, Bates ER, Bittl JA et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2016; 68 (10): 1082–115. DOI: 10.1016/j.jacc.2016.03.513
10. Hu W, Tong J, Kuang X et al. Influence of proton pump inhibitors on clinical outcomes in coronary heart disease patients receiving aspirin and clopidogrel: A meta-analysis. Medicine (Baltimore) 2018; 97 (3): e9638. DOI: 10.1097/MD.0000000000009638
11. Serbin MA, Guzauskas GF, Veenstra DL. Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis. J Manag Care Spec Pharm 2016; 22 (8): 939–47. DOI: 10.18553/jmcp.2016.22.8.939
12. Zairis MN, Tsiaousis GZ, Patsourakos NG et al. The impact of treatment with omeprazole on the effectiveness of clopidogrel drug therapy during the first year after successful coronary stenting. Can J Cardiol 2010; 26 (2): e54-7.
13. Evanchan J, Donnally MR, Binkley P, Mazzaferri E. Recurrence of acute myocardial infarction in patients discharged on clopidogrel and a proton pump inhibitor after stent placement for acute myocardial infarction. Clin Cardiol 2010; 33 (3): 168–71. DOI: 10.1002/clc.20721
14. Harjai KJ, Shenoy C, Orshaw P et al. Clinical outcomes in patients with the concomitant use of clopidogrel and proton pump inhibitors after percutaneous coronary intervention: an analysis from the Guthrie Health Off-Label Stent (GHOST) investigators. Circ Cardiovasc Interv 2011; 4 (2): 162–70. DOI: 10.1161/CIRCINTERVENTIONS.110.958884
15. Aihara H, Sato A, Takeyasu N et al. Effect of individual proton pump inhibitors on cardiovascular events in patients treated with clopidogrel following coronary stenting: results from the Ibaraki Cardiac Assessment Study Registry. Catheter Cardiovasc Interv 2012; 80 (4): 556–63. DOI: 10.1002/ccd.23327
16. Bundhun PK, Teeluck AR, Bhurtu A, Huang WQ. Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty: a systematic review and meta-analysis of recently published studies (2012–2016). BMC Cardiovasc Disord 2017; 17 (1): 3. DOI: 10.1186/s12872-016-0453-6
17. Douglas IJ, Evans SJ, Hingorani AD et al. Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs. BMJ 2012; 345: e4388. DOI: 10.1136/bmj.e4388
18. Bhurke SM, Martin BC, Li C et al. Effect of the clopidogrel-proton pump inhibitor drug interaction on adverse cardiovascular events in patients with acute coronary syndrome. Pharmacotherapy 2012; 32 (9): 809–18. DOI: 10.1002/j.1875-9114.2012.01112.x
19. Dunn SP, Steinhubl SR, Bauer D et al. Impact of proton pump inhibitor therapy on the efficacy of clopidogrel in the CAPRIE and CREDO trials. J Am Heart Assoc 2013; 2 (1): e004564. DOI: 10.1161/JAHA.112.004564
20. Goodman SG, Clare R, Pieper KS et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation 2012; 125 (8): 978–86. DOI: 10.1161/CIRCULATIONAHA.111.032912
21. Hsieh CF, Huang WF, Chiang YT et al. Effects of Clopidogrel and Proton Pump Inhibitors on Cardiovascular Events in Patients with Type 2 Diabetes Mellitus after Drug-Eluting Stent Implantation: A Nationwide Cohort Study. PLoS One 2015; 10 (8): e0135915. DOI: 10.1371/journal.pone.0135915
22. Chitose T, Hokimoto S, Oshima S et al. Clinical outcomes following coronary stenting in Japanese patients treated with and without proton pump inhibitor. Circ J 2012; 76 (1): 71–8.
23. Macaione F, Montaina C, Evola S et al. Impact of dual antiplatelet therapy with proton pump inhibitors on the outcome of patients with acute coronary syndrome undergoing drug-eluting stent implantation. ISRN Cardiol 2012; 2012: 692761. DOI: 10.5402/2012/692761
24. Burkard T, Kaiser CA, Brunner-La Rocca H et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med 2012; 271 (3): 257–63. DOI: 10.1111/j.1365-2796.2011.02423.x.
25. Gargiulo G, Costa F, Ariotti S et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: Insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study trial. Am Heart J 2016; 174: 95–102. DOI: 10.1016/j.ahj.2016.01.015
26. Steinhubl SR, Berger PB, Mann JT 3rd et al; CREDO Investigators. Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288 (19): 2411–20.
27. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet 1996; 348 (9038): 1329–39.
28. Huang B, Huang Y, Li Y et al. Adverse cardiovascular effects of concomitant use of proton pump inhibitors and clopidogrel in patients with coronary artery disease: a systematic review and meta-analysis. Arch Med Res 2012; 43 (3): 212–24. DOI: 10.1016/j.arcmed.2012.04.004
29. Focks JJ, Brouwer MA, van Oijen MG et al. Concomitant use of clopidogrel and proton pump inhibitors: impact on platelet function and clinical outcome- a systematic review. Heart 2013; 99 (8): 520–7. DOI: 10.1136/heartjnl-2012-302371
30. Demcsák A, Lantos T, Bálint ER et al. PPIs Are Not Responsible for Elevating Cardiovascular Risk in Patients on Clopidogrel-A Systematic Review and Meta-Analysis. Front Physiol 2018; 9: 1550. DOI: 10.3389/fphys.2018.01550
31. Melloni C, Washam JB, Jones WS et al. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review. Circ Cardiovasc Qual Outcomes 2015; 8 (1): 47–55. DOI: 10.1161/CIRCOUTCOMES.114.001177
32. Ng FH, Tunggal P, Chu WM et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol 2012; 107 (3): 389–96. DOI: 10.1038/ajg.2011.385
33. Yano H, Tsukahara K, Morita S et al. Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: a prospective, randomized, multicenter study. Circ J 2012; 76 (11): 2673–80.
34. Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology 2011; 140 (3): 791–8. DOI: 10.1053/j.gastro.2010.11.056
35. Ren YH, Zhao M, Chen YD et al. Omeprazole affects clopidogrel efficacy but not ischemic events in patients with acute coronary syndrome undergoing elective percutaneous coronary intervention. Chin Med J (Engl) 2011; 124 (6): 856–61.
36. Bhatt DL, Cryer BL, Contant CF et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010; 363 (20): 1909–17. DOI: 10.1056/NEJMoa1007964
37. Cai J, Wu Q, Fan L et al. Impact of different proton pump inhibitors on the antiplatelet activity of clopidogrel in combination with aspirin for patients undergoing coronary stent implantation. Zhongguo Ying Yong Sheng Li Xue Za Zhi 2010; 26 (3): 266–9.
38. Weisz G, Smilowitz NR, Kirtane AJ et al. Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study. Circ Cardiovasc Interv 2015; 8 (10). pii: e001952. DOI: 10.1161/CIRCINTERVENTIONS.114.001952
39. O'Donoghue ML, Braunwald E, Antman EM et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet 2009; 374 (9694): 989–97. DOI: 10.1016/S0140-6736(09)61525-7
40. Tentzeris I, Jarai R, Farhan S et al. Impact of concomitant treatment with proton pump inhibitors and clopidogrel on clinical outcome in patients after coronary stent implantation. Thromb Haemost 2010; 104 (6): 1211–8. DOI: 10.1160/TH10-04-0218
41. Sarafoff N, Sibbing D, Sonntag U et al. Risk of drug-eluting stent thrombosis in patients receiving proton pump inhibitors. Thromb Haemost 2010; 104 (3): 626–32. DOI: 10.1160/TH09-11-0800
42. Chandrasekhar J, Bansilal S, Baber U et al. Impact of proton pump inhibitors and dual antiplatelet therapy cessation on outcomes following percutaneous coronary intervention: Results From the PARIS Registry. Catheter Cardiovasc Interv 2017; 89 (7): E217-E225. DOI: 10.1002/ccd.26716
43. Комаров А.Л., Шахматова О.О., Мурасеева В. и др. Прием ингибиторов протонной помпы и прогноз пациентов после плановых чрескожных коронарных вмешательств. Терапевтический архив. 2018; 9: 92–100.
[Komarov A.L., Shakhmatova O.O., Muraseeva V. et al. Priem ingibitorov protonnoi pompy i prognoz patsientov posle planovykh chreskozhnykh koronarnykh vmeshatel'stv. Terapevticheskii arkhiv. 2018; 9: 92–100 (in Russian).]
________________________________________________
2. Ibanez B, James S, Agewall S et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2018; 39 (2): 119–77. DOI: 10.1093/eurheartj/ehx393
3. Roffi M, Patrono C, Collet JP et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37 (3): 267–315. DOI: 10.1093/eurheartj/ehv320
4. Valgimigli M, Bueno H, Byrne RA et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39 (3): 213–60. doi: 10.1093/eurheartj/ehx419
5. Gutermann IK, Niggemeier V, Zimmerli LU et al. Gastrointestinal bleeding and anticoagulant or antiplatelet drugs: systematic search for clinical practice guidelines. Medicine (Baltimore). 2015; 94 (1): e377. DOI: 10.1097/MD.0000000000000377
6. Neumann FJ, Sousa-Uva M, Ahlsson A et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019; 40 (2): 87–165. DOI: 10.1093/eurheartj/ehy394
7. Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg 2016; 50 (5): e1-e88.
8. Heidbuchel H, Verhamme P, Alings M et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15 (5): 625–51. DOI: 10.1093/europace/eut083
9. Levine GN, Bates ER, Bittl JA et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2016; 68 (10): 1082–115. DOI: 10.1016/j.jacc.2016.03.513
10. Hu W, Tong J, Kuang X et al. Influence of proton pump inhibitors on clinical outcomes in coronary heart disease patients receiving aspirin and clopidogrel: A meta-analysis. Medicine (Baltimore) 2018; 97 (3): e9638. DOI: 10.1097/MD.0000000000009638
11. Serbin MA, Guzauskas GF, Veenstra DL. Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis. J Manag Care Spec Pharm 2016; 22 (8): 939–47. DOI: 10.18553/jmcp.2016.22.8.939
12. Zairis MN, Tsiaousis GZ, Patsourakos NG et al. The impact of treatment with omeprazole on the effectiveness of clopidogrel drug therapy during the first year after successful coronary stenting. Can J Cardiol 2010; 26 (2): e54-7.
13. Evanchan J, Donnally MR, Binkley P, Mazzaferri E. Recurrence of acute myocardial infarction in patients discharged on clopidogrel and a proton pump inhibitor after stent placement for acute myocardial infarction. Clin Cardiol 2010; 33 (3): 168–71. DOI: 10.1002/clc.20721
14. Harjai KJ, Shenoy C, Orshaw P et al. Clinical outcomes in patients with the concomitant use of clopidogrel and proton pump inhibitors after percutaneous coronary intervention: an analysis from the Guthrie Health Off-Label Stent (GHOST) investigators. Circ Cardiovasc Interv 2011; 4 (2): 162–70. DOI: 10.1161/CIRCINTERVENTIONS.110.958884
15. Aihara H, Sato A, Takeyasu N et al. Effect of individual proton pump inhibitors on cardiovascular events in patients treated with clopidogrel following coronary stenting: results from the Ibaraki Cardiac Assessment Study Registry. Catheter Cardiovasc Interv 2012; 80 (4): 556–63. DOI: 10.1002/ccd.23327
16. Bundhun PK, Teeluck AR, Bhurtu A, Huang WQ. Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty: a systematic review and meta-analysis of recently published studies (2012–2016). BMC Cardiovasc Disord 2017; 17 (1): 3. DOI: 10.1186/s12872-016-0453-6
17. Douglas IJ, Evans SJ, Hingorani AD et al. Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs. BMJ 2012; 345: e4388. DOI: 10.1136/bmj.e4388
18. Bhurke SM, Martin BC, Li C et al. Effect of the clopidogrel-proton pump inhibitor drug interaction on adverse cardiovascular events in patients with acute coronary syndrome. Pharmacotherapy 2012; 32 (9): 809–18. DOI: 10.1002/j.1875-9114.2012.01112.x
19. Dunn SP, Steinhubl SR, Bauer D et al. Impact of proton pump inhibitor therapy on the efficacy of clopidogrel in the CAPRIE and CREDO trials. J Am Heart Assoc 2013; 2 (1): e004564. DOI: 10.1161/JAHA.112.004564
20. Goodman SG, Clare R, Pieper KS et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation 2012; 125 (8): 978–86. DOI: 10.1161/CIRCULATIONAHA.111.032912
21. Hsieh CF, Huang WF, Chiang YT et al. Effects of Clopidogrel and Proton Pump Inhibitors on Cardiovascular Events in Patients with Type 2 Diabetes Mellitus after Drug-Eluting Stent Implantation: A Nationwide Cohort Study. PLoS One 2015; 10 (8): e0135915. DOI: 10.1371/journal.pone.0135915
22. Chitose T, Hokimoto S, Oshima S et al. Clinical outcomes following coronary stenting in Japanese patients treated with and without proton pump inhibitor. Circ J 2012; 76 (1): 71–8.
23. Macaione F, Montaina C, Evola S et al. Impact of dual antiplatelet therapy with proton pump inhibitors on the outcome of patients with acute coronary syndrome undergoing drug-eluting stent implantation. ISRN Cardiol 2012; 2012: 692761. DOI: 10.5402/2012/692761
24. Burkard T, Kaiser CA, Brunner-La Rocca H et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med 2012; 271 (3): 257–63. DOI: 10.1111/j.1365-2796.2011.02423.x.
25. Gargiulo G, Costa F, Ariotti S et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: Insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study trial. Am Heart J 2016; 174: 95–102. DOI: 10.1016/j.ahj.2016.01.015
26. Steinhubl SR, Berger PB, Mann JT 3rd et al; CREDO Investigators. Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288 (19): 2411–20.
27. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet 1996; 348 (9038): 1329–39.
28. Huang B, Huang Y, Li Y et al. Adverse cardiovascular effects of concomitant use of proton pump inhibitors and clopidogrel in patients with coronary artery disease: a systematic review and meta-analysis. Arch Med Res 2012; 43 (3): 212–24. DOI: 10.1016/j.arcmed.2012.04.004
29. Focks JJ, Brouwer MA, van Oijen MG et al. Concomitant use of clopidogrel and proton pump inhibitors: impact on platelet function and clinical outcome- a systematic review. Heart 2013; 99 (8): 520–7. DOI: 10.1136/heartjnl-2012-302371
30. Demcsák A, Lantos T, Bálint ER et al. PPIs Are Not Responsible for Elevating Cardiovascular Risk in Patients on Clopidogrel-A Systematic Review and Meta-Analysis. Front Physiol 2018; 9: 1550. DOI: 10.3389/fphys.2018.01550
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Авторы
А.И.Кочетков1, О.Д.Остроумова*1, Е.В.Кравченко2, О.В.Бондарец2, Т.Ф.Гусева2
1 ФГБОУ ВО «РНИМУ им. Н.И.Пирогова» Минздрава России – ОСП «Российский геронтологический научно-клинический центр». 129226, Россия, Москва, ул. 1-я Леонова, д. 16;
1 ФГБОУ ВО «РНИМУ им. Н.И.Пирогова» Минздрава России – ОСП «Российский геронтологический научно-клинический центр». 129226, Россия, Москва, ул. 1-я Леонова, д. 16;
2 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И.Евдокимова» Минздрава России. 127473, Россия, Москва, ул. Делегатская, д. 20, стр. 1
*ostroumova.olga@mail.ru
*ostroumova.olga@mail.ru
________________________________________________
Aleksei I. Kochetkov1, Olga D. Ostroumova*1, Evgenii V. Kravchenko2, Olga V. Bondarets2, Tatiana F. Guseva2
1 N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation – Russian Clinical and Research Center of Gerontology. 16, 1-ia Leonova st., Moscow, 129226, Russian Federation;
1 N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation – Russian Clinical and Research Center of Gerontology. 16, 1-ia Leonova st., Moscow, 129226, Russian Federation;
2 A.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian Federation. 1, 20, Delegatskaia st., Moscow, 127473, Russian Federation
*ostroumova.olga@mail.ru
*ostroumova.olga@mail.ru
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